The endorsement by the E.U. Committee of Permanent Representatives of the political agreement reached by the Lithuanian E.U. Council Presidency and the European Parliament, on the compromise text of the proposed E.U. Clinical Trials Regulation looks set to not deliver on the initial goal set by the European Commission (E.C.) when it launched the process in July 2012 of making the E.U. a more attractive location to conduct clinical trials.
Steve Bates, BioIndustry Association (BIA) CEO, said, "Today's deal marks a milestone in simplifying the rules for conducting clinical trials in the E.U. But even the E.C. conceded that it had hoped for a more ambitious approach in line with its original proposal. I fear that the compromise in extending the timelines for approval fails to improve the attractiveness of Europe and the U.K. as a location for global clinical trials. This means U.K. patients stand to miss out on the chance to participate in developing the therapies of the future.”
Bates said, "In particular, increasing the timeline to over 100 days for clinical trial approvals for advanced and innovative therapies is unlikely to boost clinical research in the E.U. I fear this will result in a worse position for researchers in innovative bioscience companies, medical research charities and in hospitals and academia who are developing innovative treatments, than the U.K. consistently achieves at present.
"This key compromise makes it harder, not easier, to deliver on the initial goal of this piece of legislation which U.K. MEP Glenis Willmott, the European Parliament reporter, defined as 'creating many skilled jobs in the U.K. and Europe, as well as leading to new life-saving treatments and drugs',” said Bates.
However the BIA welcomes a number of the positive measures outlined in the new rules on conducting clinical trials in the E.U., including:
The political agreement reached is subject to technical finalization and formal approval by the European Parliament at Plenary and by the Council.